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    Clinical Trial Results:
    The role of induced phase 3 contractions in the control of hunger and food intake

    Summary
    EudraCT number
    		 2011-004082-33
    Trial protocol
    		 BE  
    Global end of trial date
    25 Aug 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Feb 2021
    First version publication date
    04 Feb 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    erythstom2
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02633579
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    UZLeuven
    Sponsor organisation address
    herestraat 49, leuven, Belgium, 3000
    Public contact
    Jan Tack, UZLeuven, 00 3216330147, jan.tack@med.kuleuven.be
    Scientific contact
    Jan Tack, UZLeuven, 00 3216330147, jan.tack@med.kuleuven.be
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    20 Jan 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Aug 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Investigating if contractions are necessary to induce hunger feelings, or if erythromycin has a secundary effect
    Protection of trial subjects
    only healthy volunteers could participate
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Oct 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 15
    Worldwide total number of subjects
    15
    EEA total number of subjects
    15
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    15
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 15 healthy volunteers

    Pre-assignment
    Screening details
    		 Volunteers were eligible to participate if they were healthy, aged between 18 and 60 y, had a BMI (in kg/m2) between 18 and 25, Exclusion criteria were gastrointestinal diseases, abdominal surgery (appendectomy allowed), psychiatric illnesses, and usage of drugs affecting the GIT. Not allergic to macrolide antibiotics

    Period 1
    Period 1 title
    overall trial period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 erythromycin 40 mg infusion
    Arm description
    		 at fixed time points (90, 180, and 270 min) an intravenous infusion of placebo or 40 mg erythromycin was administered over a 20-min period in a volume of 100 mL 0.9% NaCl. Administration was done in a single-blind randomized fashion. Each subject received 3 infusions during the measuring period, 2 of which were saline and 1 of which was an infusion of erythromycin
    Arm type
    		 Experimental

    Investigational medicinal product name
    erythromycin 40 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    an intravenous infusion of 40 mg erythromycin was administered over a 20-min period in a volume of 100 mL 0.9% NaCl

    Arm title
    		 placebo 0.9% NaCl infusion
    Arm description
    		 at fixed time points (90, 180, and 270 min) an intravenous infusion of placebo or 40 mg erythromycin was administered over a 20-min period in a volume of 100 mL 0.9% NaCl. Administration was done in a single-blind randomized fashion. Each subject received 3 infusions during the measuring period, 2 of which were saline and 1 of which was an infusion of erythromycin.
    Arm type
    		 Placebo

    Investigational medicinal product name
    0.9% NaCl
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    an intravenous infusion of 100 mL 0.9% NaCl (= placebo) was administered over a 20-min period

    Number of subjects in period 1
    		erythromycin 40 mg infusion placebo 0.9% NaCl infusion
    Started
    15
    15
    Completed
    15
    15

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall trial period
    Reporting group description
    		 -

    Reporting group values
    		 overall trial period Total
    Number of subjects
    		 15 15
    Age categorical
    healthy volunteers
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 15 15
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    healthy volunteers
    Units: years
        arithmetic mean (standard deviation)
    		 28 ( 3 ) -
    Gender categorical
    Units: Subjects
        Female
    		 9 9
        Male
    		 6 6

    End points

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    End points reporting groups
    Reporting group title
    erythromycin 40 mg infusion
    Reporting group description
    		 at fixed time points (90, 180, and 270 min) an intravenous infusion of placebo or 40 mg erythromycin was administered over a 20-min period in a volume of 100 mL 0.9% NaCl. Administration was done in a single-blind randomized fashion. Each subject received 3 infusions during the measuring period, 2 of which were saline and 1 of which was an infusion of erythromycin

    Reporting group title
    placebo 0.9% NaCl infusion
    Reporting group description
    		 at fixed time points (90, 180, and 270 min) an intravenous infusion of placebo or 40 mg erythromycin was administered over a 20-min period in a volume of 100 mL 0.9% NaCl. Administration was done in a single-blind randomized fashion. Each subject received 3 infusions during the measuring period, 2 of which were saline and 1 of which was an infusion of erythromycin.

    Primary: increase of food intake

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    End point title
    		 increase of food intake
    End point description
    End point type
    Primary
    End point timeframe
    In comparison with placebo, administration of erythromycin significantly (Wilcoxon’s signed rank test, P = 0.015) increased food intake, with 53% +- 13% of erythromycin infusions inducing food intake compared with 10% +- 5% for placebo administration
    End point values
    		 erythromycin 40 mg infusion placebo 0.9% NaCl infusion
    Number of subjects analysed
    15
    15
    Units: percentage
        arithmetic mean (standard deviation)
    53 ( 13 )
    10 ( 5 )
    Statistical analysis title
    		 food intake
    Comparison groups
    erythromycin 40 mg infusion v placebo 0.9% NaCl infusion
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.015
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [1] - erythromycin versus placebo. This is a cross over study. All 15 subjects participated in both study arms

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    For each individual, corresponds to timeframe of study participation (from signing of informed consent until last visit).
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: no adverse events were reported

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/26817505
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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